EMPALINA
(10 mg/5 mg and 25 mg/5 mg) Film Coated Tablets
Composition:
Each film coated tablet contains:
•    10 mg empagliflozin+5 mg linagliptin
•    25 mg empagliflozin+5 mg linagliptin 
Mechanism of Action:
This product combines 2 antihyperglycemic agents with complementary mechanisms of action to improve glycemic control in patients with type 2 diabetes: empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor.
Empagliflozin
Sodium-glucose co-transporter 2 (SGLT2) is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. Empagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
Linagliptin
Linagliptin is an inhibitor of DPP-4, an enzyme that degrades the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Thus, linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation. 
Indications:
This product is a combination of empagliflozin and linagliptin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate.
Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease . However, the effectiveness of THIS PRODUCT on reducing the risk of cardiovascular death in adults with type 2 diabetes mellitus and cardiovascular disease has not been established.
Contraindications:
This product is contraindicated in patients with:
•Severe renal impairment, end-stage renal disease, or dialysis .
•A history of serious hypersensitivity reaction to empagliflozin, linagliptin, or any of the excipients in THIS PRODUCT.
Dosage and Administration:
The recommended dose of this product is 10 mg empagliflozin/5 mg linagliptin once daily in the morning, taken with or without food. In patients tolerating this product, the dose may be increased to 25 mg empagliflozin/5 mg linagliptin once daily.
Patients With Renal Impairment:
Assessment of renal function is recommended prior to initiation of this product and periodically thereafter.
This product should not be initiated in patients with an eGFR less than 45 mL/min/1.73 m².
No dose adjustment is needed in patients with an eGFR greater than or equal to 45 mL/min/1.73 m².
This product should be discontinued if eGFR is persistently less than 45 mL/min/1.73 m².
Packaging:
Carton Pack of 30 Film Coated tablets for both strengths.